Drug Facts

Active ingredients

Octocrylene 8%, Octyl methoxycinnamate 7.5%

Octisalate 5%, Oxybenzone 3%, Avobenzone 2.5%

Purpose

Sunscreen

Uses

helps prevent sunburn
If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use ony

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove

Stop use and ask a doctor

if a rash occurs

Keep out of reach of children

If this product is swallowed get medical help or contact a Poison Control Center right away.

Directions

APPLY liberally 15 minutes before sun exposure

USE a water resistant sunscreen if sweating or swimming. Sun Protection Measures. SPENDING time in the sun increases your risk of skin cancer and early skin aging. To decreases risk, regularly use a sunsreen with a broad spectrum SPF of 15 or higher and other sun protection measures including
LIMIT time in the sun especially between 10am and 2pm
WEAR long sleeved shirts, pants, hats and sunglasses
REAPPLY at least every 2 hours
USE a water resistant sunscreen if sweating or swimming
Children under 6 months ask a doctor.

Other Information

Protect this product from excessive heat and direct sun

Inactive ingrediets

CAPRYLIC/CAPROC TRIGLYCERIDE, HELIANTHUS ANNUUS SEED OIL, Cold pressed organic COCOS NUCIFERA OIL, C12-15 ALKYL BENZOATE, BEESWAX, BUTYROSPERMUM PARKII BUTTER, TRIACONTANYL PVP, PARFUM, TOCOPHEROL

Questions?

Visit www.cocooil.com.au or call +64 9 361 4191

Package Labeling:

Label

COCOOIL SPF30
octocrylene, octinoxate, octisalate, oxybenzone, avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72645-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	80 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 mg in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
YELLOW WAX (UNII: 2ZA36H0S2V)
TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
TOCOPHEROL (UNII: R0ZB2556P8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72645-002-01	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/18/2020

Labeler - Cocooil Limited (594933650)

Cocooil SPF30